Location: Boston,MA, USA
Early Career Opportunity in Drug Development Data Science and Analytics
Company: BioPier, LLC. (a Veramed Company)
Location: Burlington, MA
Position: Statistical Programming and Biostatistics
Type: Full-time
Brief Description: BioPier, LLC., a Veramed company, is seeking highly motivated, inquisitive, coachable and skilled programmers. We prefer a master's degree or higher in STEM disciplines, who have strong programming, analytical, and data science skills and are looking to launch their careers in the fast-growing field of drug development and clinical data science. This position offers a unique opportunity to work alongside the talented BioPier team, receive hands-on training, and contribute to high-impact projects in the clinical and biostatistics domain. This is a paid, full-time benefit eligible position.
Position Responsibilities:
Statistical Programming:
· Conduct Phase I-IV Clinical Study Reports (CSRs) to evaluate study safety and efficacy
· Work on data science and standardization projects, including CDASH, CDISC SDTM, and ADaM
· Compile Integrated Summaries of Safety and Efficacy for drug approval
· Prepare regulatory patient safety reports (PBRER, DSUR, PSUR, SWG, SRT, EU-RMP, DMC, IB)
· Support Independent Data Monitoring Committees and create patient profiles and narratives
Biostatistics Services:
· Provide statistical input in clinical trial design and protocol development
· Perform power and sample size calculations
· Develop randomization schemes and conduct exploratory data analysis
· Draft Statistical Analysis Plans (SAP) and design tables, figures, and listing shells
· Contribute statistical expertise to Clinical Study Reports and regulatory presentations
Qualifications:
· Masters degree in any STEM field with a strong analytical, programming, and data science foundation
· Proficient SaS programming required
· Ability to quickly learn and adapt to complex biostatistics and clinical data science tasks
· Motivation to excel in a fast-paced, collaborative environment
BioPier offers a supportive, dynamic environment where recent graduates can build foundational expertise and make a meaningful impact in healthcare. Visit veramedinc.com to learn more about our team and accomplishments.